BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURGIFRESH SUB-MICRON MASK NO. 901008-000

    K Number: K893417 · Decision Jun 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    30
    Review Days
    51

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    Basic Information

    Device Name
    SURGIFRESH SUB-MICRON MASK NO. 901008-000
    K Number
    K893417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Texas Medical Products, Inc.
    Date Received
    May 2, 1989
    Decision Date
    June 22, 1989
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FXX Mask, Surgical

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